Tuesday, August 22, 2017

A comment to the following article:
https://mastercontrolinc.blogspot.com/2017/08/is-510k-process-as-worthless-as-federal.html?source=sm-qt

Excellent analysis. My experience over several
decades of 510(k) submissions, is that the process and documentation demands
have become much more rigorous, with more data required. The 20 hour average
cited in your article, if based on actual FDA averages must be considered in
light of the fact that the reviewer starts and stops the "clock" when
requesting additional information from the submitter. Not exactly like a lawyer
bills a client. And that average must also be considered in light of the fact
that the majority of 510(k)s are basically "me too" products, i.e.,
the whole 510(k) process is predicated upon the requirement to identify a
"predicate" device, and then prove "substantial
equivalence" to it. The principle being that the new device poses
basically the same risks (and benefits) as the predicate. and is cleared on
that basis. Yes some 510(k) products push the envelope, but then the Agency
usually requires an IDE (Investigational Device Exemption) submission leading
to clinical trials prior to the submission of the 510(k). I very much agree
that today's requirements are much more extensive than those existing in 1982.
The e-copy requirement is not only for filing purposes, but to allow the review
to easily involve others in the Agency when questions of safety and efficacy arise.
Requirements such as Design Control, started in 1996-7, device risk management
per ISO 14971, and human factors engineering / usability engineering per IEC
62366-1:2015, and -2:2016, and similar, have also been incrementally added as
appropriate. And a growing list of software / hardware requirements. New
guidance documents, which state that they are voluntary, but I have found to be
required if applicable to a submission, e.g., the documentation required for
devices containing software, cybersecurity, et al. The sheer volume of
documentation required in a submission between 1982 and 2017, has grown
exponentially as a result, and my experience is that it is all given careful
study based on the follow-up questions I receive from the reviewer(s).